The European Medicines Agency (EMA) will assess the Serum Institute of India’s (SII) Covishield manufacturing sites before approving it. However, the agency said it has no role in lifting European Union (EU) travel restrictions.
Currently, AstraZeneca’s Covid-19 vaccine Vaxzevria is used in the UK and Europe, and the EMA will be assessing the production unit of the company’s Covishield before approval.
“Even though it (Covishield) may use an analogous production technology to Vaxzevria, Covishield as such is not currently approved under EU rules,” said Violeta Pashova, Press officer of EMA, told News18 in an email response.
Explaining that the vaccines are biological products, the EMA said, “Even tiny differences in the manufacturing conditions can result in differences in the final product, and EU law, therefore, requires the manufacturing sites and production process to be assessed and approved as part of the authorisation process.”
The EMA is responsible for the scientific evaluation of medicines or vaccines for their marketing authorisation in the EU.
Answering questions about lifting EU’s travel restrictions, it said, “EMA is not responsible for any decision regarding travelling into the EU and travelling conditions associated with Covid-19 vaccination, such as the EU Digital Covid Certificate. This is a matter for the European Commission and for the individual Member States.”
According to a part of the European Commission law on ‘EU Digital Covid Certificate’ or ‘Green Pass’, member states need to accept certificates for vaccines that received EU marketing authorisation through EMA.
Adar Poonawalla, CEO of SII, announced on Monday that the company has applied for the ‘Green Pass’ to EMA. However, the EMA has denied receiving any marketing authorisation application for Covishield.
As the European Commission law gives the liberty to the member states to extend the ‘Green Pass’ to EU travellers who received a different Covid-19 vaccine, the Indian government is trying to take up the matter diplomatically with them since Covishield is WHO approved.